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Recognizing Ventricular Fibrillation From an Area of a Mobile Phone

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ClinicalTrials.gov Identifier: NCT01824212
Recruitment Status : Completed
First Posted : April 4, 2013
Last Update Posted : March 23, 2016
Sponsor:
Collaborator:
Kuopio University Hospital
Information provided by (Responsible Party):
Sakari Syvaoja, North Karelia Central Hospital

Brief Summary:

Recognition of out of hospital cardiac arrest (OHCA) during an emergency call is based on standardized questions concerning the symptoms of OHCA. With this method cardiac arrest is recognized in 50-83% of cases. When the emergency medical dispatcher identifies cardiac arrest during the emergency call the survival of the patient improves. Accurate emergency medical service response is activated promptly and bystander will receive cardiopulmonary resuscitation (CPR) instructions. It has been estimated that proper implementation of CPR instructions will save thousands of lives each year.

If the ECG could be recorded by the mobile phone, transmitted during the emergency call to the dispatch centre and analysed there with the software of a semi-automated external defibrillator(AED), the recognition of cardiac arrest could be more accurate.

The aim of this study is to examine, if AED, with minimal size electrodes within an area of a mobile phone, is able to recognize reliably ventricular fibrillation (VF), the rhythm with the best prognosis in OHCA.


Condition or disease
Ventricular Fibrillation

Detailed Description:
Dysrhythmia patients who need an implantable cardioverter defibrillator(ICD) or patients with an already implanted ICD which function needs to be revised will be recruited into this study. Our hypothesis is that the ECG and VF is recordable in 100% of cases with a semi-automatic defibrillator. In sample size calculations we compared this 100% recognition to the present situation with 80% recognition of cardiac arrest in emergency medical communication centre during emergency call. According to the power calculation of 1-sided binomial test with risk level 0.05 and power of 95 %, 22 observations is needed to detect difference between expected full successes (99 %) from the previous 80 % of successes in recognition.

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Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Recognizing Ventricular Fibrillation From an Area of a Mobile Phone
Study Start Date : November 2013
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Group/Cohort
ICD-patients
Patients to whom cardiac fibrillation will be induced during the implantation of an implantable cardioverter defibrillator (ICD) or patients with an already implanted ICD, which function needs to be revised and during the revision cardiac defibrillation will be induced.



Primary Outcome Measures :
  1. The ability of AED to recognise induced VF [ Time Frame: 24 hours ]
    The ability of AED to correctly recognise ventricular fibrillation from a bipolar ECG recorded within an area of mobile phone: is the recognition good enough to automatically divide the rhythm correctly into categories of shockable and non-shockable?


Secondary Outcome Measures :
  1. Quality of VF [ Time Frame: 24 hour ]
    The recorded rhythms will be analysed, beside an AED, by two experienced cardiologists and categorised as shockable or non-shockable. The cardiologists also will assess the quality of the recordings and grade each recording according to three categories of quality: 1, bad; 2, average; 3, good.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with severe dysrhytmia and the necessity to an implantable cardioverter defibrillator (ICD)
Criteria

Inclusion Criteria:

  • age over 18
  • ventricular fibrillation will be induced during the implantation or revision of ICD
  • patient`s informed consent

Exclusion Criteria:

  • ventricular fibrillation will not be induced during the implantation or revision of ICD

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01824212


Locations
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Finland
North Karelia Central Hospital
Joensuu, Finland, 80210
Kuopio University Hospital
Kuopio, Finland, 70211
Sponsors and Collaborators
North Karelia Central Hospital
Kuopio University Hospital
Investigators
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Study Director: Helena Jäntti, MD, PhD Kuopio University Hospital
Principal Investigator: Sakari Syväoja, MD North Karelia Central Hospital

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Responsible Party: Sakari Syvaoja, MD, North Karelia Central Hospital
ClinicalTrials.gov Identifier: NCT01824212     History of Changes
Other Study ID Numbers: NKCHAne001
First Posted: April 4, 2013    Key Record Dates
Last Update Posted: March 23, 2016
Last Verified: March 2016

Keywords provided by Sakari Syvaoja, North Karelia Central Hospital:
Ventricular fibrillation
Cardiac arrest
Mobile technology

Additional relevant MeSH terms:
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Ventricular Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes